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Published on: February 28, 2012
Meta-analysis of bleeding complications associated with cardiac rhythm device implantation
Michael L Bernard1, Matthew Shotwell, Paul J Nietert
1Division of Cardiology, Medical University of South Carolina, Charleston, SC 29425, USA.
Insights
Continuing oral anticoagulation (AC) is safer than heparin-bridging strategy (HBS) for patients receiving cardiac rhythm devices. Dual antiplatelet (AP) therapy increases bleeding risk, while continuing AC does not significantly elevate it.
Area of Science:
- Cardiology
- Medical Devices
- Pharmacology
Background:
- Patients with cardiac rhythm devices often require antiplatelet (AP) and/or anticoagulant (AC) therapy.
- Current guidelines suggest heparin-bridging strategy (HBS) for anticoagulated patients at moderate/high risk of thrombosis.
- Evidence suggests continued oral anticoagulation may have a lower bleeding risk than HBS.
Purpose of the Study:
- To conduct a meta-analysis evaluating bleeding complications associated with cardiac device implantation.
- To compare bleeding risks across different perioperative antiplatelet (AP) and anticoagulant (AC) therapy strategies.
Main Methods:
- A systematic literature search of PubMed and Cochrane Database was performed.
- Included studies compared bleeding complications in device recipients across various therapeutic groups: no therapy, aspirin only, AC held, AC continued, dual AP, and HBS.
- Bleeding complications were defined as hematoma, transfusion, or prolonged hospital stay.
Main Results:
- Analysis of 13 articles involving 5978 patients revealed an overall bleeding complication rate of 4.6%.
- Heparin-bridging strategy (HBS) was associated with the highest bleeding incidence (14.6%), significantly increasing bleeding odds compared to holding or continuing AC.
- Continuing AC (1.6x odds) or aspirin only (1.5x odds) showed no significant increase in bleeding compared to no therapy.
Conclusions:
- Continuing oral anticoagulation (AC) is a safer perioperative strategy than heparin-bridging strategy (HBS) for patients undergoing cardiac device implantation.
- Dual antiplatelet (AP) therapy significantly increases bleeding risk, whereas continuing AC does not appear to elevate bleeding complications compared to no therapy.
Background:
Many patients receiving cardiac rhythm devices have conditions requiring antiplatelet (AP) and/or anticoagulant (AC) therapy. Current guidelines recommend a heparin-bridging strategy (HBS) for anticoagulated patients with moderate/high risk for thrombosis. Several studies reported lower bleeding risk with continued oral anticoagulation rather than HBS. The best strategy for perioperative management of patients on AP therapy is less clear. The present study was designed as a meta-analysis of device implantation-associated bleeding complications using different AC/AP therapies.
Methods And Results:
PubMed and Cochrane Database searches identified articles based on design, outcomes, and available data. Device recipients were grouped as follows: no therapy, aspirin only, AC held, AC continued, dual AP, and HBS. The primary outcome was defined as a bleeding complication including hematoma, transfusion, or prolonged hospital stay. Thirteen articles were identified for analysis including 5978 patients. The combined incidence of bleeding complications was 274 of 5978 (4.6%), ranging from 2.2% (no therapy) to 14.6% (HBS). The estimated odds of bleeding were increased by 8.3 (95% CI, 5.5-12.9) times in the HBS group, 5.0 (95% CI, 3.0-8.3) for dual AP therapy, 1.7 (95% CI, 1.0-3.1) for AC held, 1.6 (95% CI, 0.9-2.6) for AC continued, and 1.5 (95% CI, 0.9-2.3) for aspirin only relative to the no therapy group. HBS significantly increased bleeding events compared with holding or continuing AC. Continuing AC did not increase bleeding events compared with no therapy.
Conclusions:
Continuing AC appears safer than HBS for device implantation. Dual AP therapy but not continuing AC carries a significant risk of bleeding.
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